It was reported through post market studies increased pain was experienced in the back of a patient with a spine procedure.The date of procedure was on (b)(6) 2023 with levels l2-l3 treated with cage and construct.Post-operatively patient experienced increased back pain possibly linked to the initial procedure.This report is for one eit plif, h 10mm, 8°, 22/9 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b3: unknown event date.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: reporter came through post market; no facility or contact available.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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